NCT01115309 - XprESS Registry Study | Crick

Overview

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Sinusitis

Interventions

XprESS Balloon DeviceDEVICE

Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use * Willing and able to provide consent Exclusion Criteria: * Known Samter's Triad * History of primary ciliary dysfunction * History of cystic fibrosis * Known to be immunosuppressed * Hemophilia * Currently enrolled in another pre-approval investigational study

Locations (1)

Texas Sinus Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Safety Assessments

Adverse event reporting as related to XprESS device or procedure

Time frame: 1 month after procedure

Secondary Outcomes

Sino-Nasal Outcome Test (SNOT-20) at 1 Month

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Time frame: Baseline and 1 month after procedure

SNOT-20 at 6 Months

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Time frame: Baseline and 6 months post procedure

SNOT-20 at 12 Months

The 20-item Sino-Nasal Outcome Test (SNOT-20) is a validated, patient-reported outcome assessment to measure the presence and severity of symptoms of chronic rhinosinusitis. Each symptom is scored from 0 (no problem) to 5 (as bad as it can be). The overall score is the mean of the 20 individual items, with a range from 0 to 5 with higher scores indicating greater disease severity. A difference of 0.8 has been determined to be the minimal clinically important difference (MCID) for the SNOT-20.

Time frame: Baseline and 12 months post procedure